Antithrombotic Therapy to Ameliorate Complications of COVID-19 ( ATTACC )
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04372589|
Recruitment Status : Not yet recruiting
First Posted : May 4, 2020
Last Update Posted : May 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID-19 Heparin Pneumonia Anticoagulant||Drug: Heparin||Not Applicable|
This is a prospective, open-label, randomized, multicentre, adaptive clinical trial to establish whether therapeutic-dose parenteral anticoagulation improves outcomes for COVID-19 positive participants (e.g., reduces intubation or mortality, etc.).
Participants will be randomized either to the investigational arm (to get therapeutic anticoagulation for 14 days or until hospital discharge/liberation from supplemental oxygen), or to the control arm (to get usual care which will include thromboprophylactic dose anticoagulation according to local practice).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Antithrombotic Therapy to Ameliorate Complications of COVID-19|
|Estimated Study Start Date :||May 2020|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2021|
Experimental: Investigational arm
Participants randomized to the investigational arm will receive therapeutic anticoagulation for 14 days (or until hospital discharge or liberation from supplemental oxygen >24 hours if previously required, whichever comes first) with heparin, with preference for subcutaneous low molecular weight heparin (enoxaparin preferred, although dalteparin or tinzaparin are also acceptable, as available) if no contraindication is present; alternatively, intravenous unfractionated heparin infusion may be used.
Low molecular weight heparin (LMWH) Preferred therapeutic anticoagulant is enoxaparin. Generally regimens: 1.5 mg/kg subcutaneous once daily or 1 mg/kg subcutaneous twice daily. Alternatively, other subcutaneous LMWH used, including tinzaparin (175 anti-Xa IU/kg subcutaneous once daily) or dalteparin (200 IU/kg subcutaneous once daily or 100 IU/kg subcutaneous twice a day).
Unfractionated heparin (UFH) Commenced, administered, and monitored according to local hospital policy, and guidelines that are used for the treatment of venous thromboembolism (i.e. not for acute coronary syndrome). Intravenous infusion of UFH is according to total body weight and pragmatically adjusted according to local institutional policy to achieve an activated partial thromboplastin time (aPTT) of 1.5-2.5x the reference value. If UFH is used, the availability of a local hospital policy that has specifies an aPTT target in this range or an anti-Xa value is a requirement.
No Intervention: Control arm
Participants will receive usual care of thromboprophylactic dose anticoagulation according to local practice.
- Intubation and mortality [ Time Frame: 30 days ]Any need for invasive mechanical ventilation or mechanical ventilation, and occurrence of death within 30 days following randomization
- Hospital-free days [ Time Frame: 30 days ]Days alive without staying overnight at a hospital 30 days post randomization
- Thrombocytopenia [ Time Frame: 30 days ]Any thrombocytopenia attributed to Heparin within 30 days following randomization
- Bleeding [ Time Frame: 30 days ]If patient experiences bleeding (1) in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome 30 days after randomization; and/or (2) causing a fall in hemoglobin level of ≥20 g/L, or leading to transfusion of 2 or more units of whole blood or red cells.
- Transfusion [ Time Frame: 30 days ]Transfusion of 2 or more more units of whole blood or red cells due to hemoglobin level of ≥20 g/L within 30 days following randomization
- ICU-free days [ Time Frame: 30 days ]Whether patient was admitted to the ICU within 30 days following randomization
- Ventilator-free days [ Time Frame: 30 days ]Number of days alive without the use of a ventilator 30 days following randomization.
- Type of ventilator used [ Time Frame: 30 days ]Whether or not patient needed non-invasive mechanical ventilation or high flow nasal cannula 30 days following randomization
- Organ support-free [ Time Frame: 21 days ]Organ support-free days 21 days after randomization
- Myocardial infarction [ Time Frame: 30 days and 90 days ]Whether patients experience a myocardial infarction 30 days and 90 days from randomization
- Ischaemic stroke [ Time Frame: 30 days and 90 days ]Whether patients experience an ischaemic stroke 30 days and 90 days from randomization.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04372589
|Contact: Ryan Zarychanski, MDfirstname.lastname@example.org|
|Ottawa, Ontario, Canada, K1H 8L6|
|Contact: Marc Carrier, MD 613-737-8899 ext 73034 email@example.com|
|Sunnybrook Research Institute|
|Toronto, Ontario, Canada, M4N 3M5|
|Contact: Jean-Philippe Galanaud, MD 416-480-5953 Jean-Philippe.Galanaud@sunnybrook.ca|
|Toronto General Hospital|
|Toronto, Ontario, Canada, M5G 2C4|
|Contact: Ewan Goligher, MD 416-586-8449 Ewan.Goligher@uhn.ca|
|Contact: Patrick Lawler 416-340-3141 Patrick.Lawler@uhn.ca|